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| Name | Class |
|---|---|
| University of Applied Sciences of Western Switzerland | OTHER |
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The objective of this study is to validate a different version of the 6 minutes Walk Test (6minWT), the 6minWT on 6 meters, instead of the 30 meters.
The secondary objectives are to verify the reliability of this new version and to analyze the possible differences between the 6minWT6 and the 6minWT30 (according to speed at half-turn, other parameters: age, gender, height, EDSS score, type of disease, time since relapse).
The 6minWT is used by physiotherapists to monitor the walking endurance abilities of multiple sclerosis (MS) patients. The protocol for this test recommends a distance of 30 meters (6minWT30) to perform the test. However, this distance is not always available in practices and patients' homes. The aim of this study is therefore to validate a protocol over a distance of 6 meters (6minWT6) and to evaluate its reliability : intra-evaluator and test-retest.
The project focuses on the population of walking patients with MS. Inclusion: adults, confirmed diagnosis of MS, Expanded Disability Status Scale (EDSS) score 3 to 6.5, or be able to walk 30 metres with or without aids, good understanding of French, have already completed a 6-minute walking test, be able to give consent by signature.
Exclusion: Lung disease, heart disease, co-morbidity preventing 6minWT, relapse in the last 3 months, chronic fatigue ≥ at 8 (Visual Analog Score-Fatigue or Rochester Fatigue Diary).
21 participants will be needed to obtain a good correlation coefficient, which is the objective of the validation of the new version of the 6minWT. The alpha was set at 0.01, the power at 0.9 for a correlation of 0.8.
Each patient will enter the study for one week, corresponding to two visits. The participant will perform the 6minWT6 and the 360 Degree Turn Test the first day and the 6minWT30 followed by the 6minWT6 after up to 45 minutes rest, the second day, a week apart.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The 6-minutes Walk Test | Diagnostic Test | To walk for 6 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| The 6-minutes Walk Test on 6 Meters | The patient walk for 6 minutes back and forth in a 6-meter hallway turning around cones. | First test day |
| Measure | Description | Time Frame |
|---|---|---|
| 360 Degree Turn Test (Time) | The person must complete a full lap on himself or herself and the execution time is measured | First test day |
| 360 Degree Turn Test (Number of Steps) | The person must complete a full lap on himself or herself and the number of steps is measured |
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Inclusion Criteria:
Exclusion Criteria:
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Multiple sclerosis patient able to walk at least 30 meters, Expanded Disability Status Scale from 3 to 6.5
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| Name | Affiliation | Role |
|---|---|---|
| Kenny Guex, PhD | Haute Ecole de Santé Vaud | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haute Ecole de Santé Vaud | Lausanne | Canton of Vaud | 1011 | Switzerland |
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On 32 patients pre-screened, 4 could not be reached by phone, 1 left for another country, 1 suffered too much from heath, 4 did not met inclusion criteria and 1 finally withdrew : 21 were enrolled
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Group | Participants walked for 6 minutes on a 6-m walkway, did the 360 Degree Turn Test, walked for 6 minutes on a 30-m walkway and again a 6 m walkway. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Test Group | Participants walked for 6 minutes on a 6-m walkway, did the 360 Degree Turn Test, walked for 6 minutes on a 30-m walkway and again a 6-m walkway. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The 6-minutes Walk Test on 6 Meters | The patient walk for 6 minutes back and forth in a 6-meter hallway turning around cones. | Posted | Mean | Standard Deviation | m | First test day |
|
|
1 week
no adverse event to be reported
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Test Group | Participants walked for 6 minutes on a 6-m walkway, did the 360 Degree Turn Test and walked for 6 minutes on a 30-m walkway and again a 6-m walkway. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pr Kenny Guex, director of thesis | Haute Ecole de Santé Vaud | +41 21 316 80 46 | kenny.guex@hesav.ch |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 10, 2020 | Aug 19, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D000070857 | Walk Test |
| ID | Term |
|---|---|
| D005080 | Exercise Test |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
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| First test day |
| 6 Minute Walk Test on 30 Meters | The patient walk for 6 minutes back and forth in a 30-meter hallway turning around cones. | Second test day |
| The 6-minutes Walk Test on 6 Meters | The patient walk for 6 minutes back and forth in a 6-meter hallway turning around cones. | Second test day |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
| Type of MS | Count of Participants | Participants |
|
| Expanded Disability Status Scale | The Expanded Disability Status Scale (EDSS) is a scale aimed to quantifying disability in multiple sclerosis. The EDSS scale ranges from 0 to 10 in 0.5 unit increments. 10 is the highest level of the scale and represent death. From 0 to 3.5, people are able to walk without aid. From 3.5-6.5, people are defined by the impairment to walking. From 7, people are dependant and restricted to wheelchair or bedridden. Scoring is based on an examination by a neurologist. It was collected through the participant or direct contact with their neurologist. | Median | Inter-Quartile Range | units on a scale |
|
| Disease duration | Median | Inter-Quartile Range | years |
|
| Assistive device | Count of Participants | Participants |
|
| Time since last relapse | Median | Inter-Quartile Range | month |
|
| Medication | Count of Participants | Participants |
|
| Visual Analogue Scale for Fatigue | The Visual Analogue Scale for Fatigue is aimed to easily and quickly quantify the level of fatigue. The participant had to stick his current level of fatigue on a blank line of 10 cm where "extreme fatigue" was mentioned to the right and "no fatigue" to the left. A corresponding graduated line allowed the tester to transform the sticked level of fatigue in a unit between 0 (no fatigue) to 10 (extreme fatigue). | Median | Inter-Quartile Range | units on a scale |
|
| Regular physical activity | Median | Inter-Quartile Range | min |
|
|
| Secondary | 360 Degree Turn Test (Time) | The person must complete a full lap on himself or herself and the execution time is measured | Posted | Mean | Standard Deviation | s | First test day |
|
|
|
| Secondary | 360 Degree Turn Test (Number of Steps) | The person must complete a full lap on himself or herself and the number of steps is measured | Posted | Mean | Standard Deviation | number of steps | First test day |
|
|
|
| Secondary | 6 Minute Walk Test on 30 Meters | The patient walk for 6 minutes back and forth in a 30-meter hallway turning around cones. | Posted | Mean | Standard Deviation | m | Second test day |
|
|
|
| Secondary | The 6-minutes Walk Test on 6 Meters | The patient walk for 6 minutes back and forth in a 6-meter hallway turning around cones. | Posted | Mean | Standard Deviation | s | Second test day |
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D003933 | Diagnosis |